FDA 510(k)

Mozec NC-Rx PTCA 擴張球囊心导管

K 號：K160961 · 2016-07-30

決定日期2016-07-30

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

Mozec NC-Rx PTCA Baloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Meril Life Sciences Private Limited. It received FDA 510(k) clearance on 2016-07-30 under 510(k) number K160961. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mozec NC-Rx PTCA Baloon Dilatation Catheter?

Mozec NC-Rx PTCA Baloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2016-07-30. The listed applicant is Meril Life Sciences Private Limited. The 510(k) number is K160961.

When did Mozec NC-Rx PTCA Baloon Dilatation Catheter receive FDA 510(k) clearance?

Mozec NC-Rx PTCA Baloon Dilatation Catheter received FDA 510(k) clearance on 2016-07-30, under 510(k) number K160961.

Who is the listed applicant for Mozec NC-Rx PTCA Baloon Dilatation Catheter?

The FDA 510(k) record lists Meril Life Sciences Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mozec NC-Rx PTCA Baloon Dilatation Catheter?

The FDA product code for Mozec NC-Rx PTCA Baloon Dilatation Catheter is LOX.

其他以 Meril Life Sciences Private Limited 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：LOX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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